MRI in Ovarian Tumors | NCT05769205

Studies
MRI in Ovarian Tumors

NCT05769205

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 15, 2023Actual

Enrollment

25Estimated

Phase

Not Applicable

Conditions

Ovarian Neoplasms

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2023Estimated

Primary Completion Date

Mar 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 26, 2023

First Submission Date that Met QC Criteria

Mar 3, 2023

First Posted Date

Mar 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2023

Last Update Posted Date

Mar 15, 2023Actual

Name	Class
principle investigator	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Role of multi paramrtric MRI and MRI perfusion in indetermint ovarian lesions by using ORADS MRI

Detailed Description

Aim of study the purpose of this study is to investigate the capabilities of multi parametric MRI including DCE perfusion and DWI to discriminate between benign and malignant ovarian masses .

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
female with ovarian masses	Experimental	MRI with contrast according to the kidney function test of the patients	Device: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	MRI with contrast	female with ovarian masses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MRI in ovarian tumors	Role of parametric MRI in determint ovarian lesions by using ORADS MRI	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: females with ovarian masses

Exclusion Criteria:

females with known benign ovarian masses

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Ovaries lesions

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Maryam Farouk Sayed	Contact	01064353498		Faroukmariam54@gmail.com
Mostafa Hashem	Contact			hashemradiol@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35059059	Background	Patel RK, Garg A, Dixit R, Gandhi G, Khurana N. The role of "penumbra sign" and diffusion-weighted imaging in adnexal masses: do they provide a clue in differentiating tubo-ovarian abscess from ovarian malignancy? Pol J Radiol. 2021 Dec 15;86:e661-e671. doi: 10.5114/pjr.2021.111986. eCollection 2021.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases